Intraject is a needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6 mg sumatriptan. Healthy Individuals will be enrolled for a series of 3 injections over 2 days. Assessment of Local Site Signs will be recorded for up to 5 days, as needed.
This study will evaluate the extent, persistence, and any cumulative effects on skin tissue by assessing local injection site reactions (bleeding, swelling, erythema, bruising) following repeated administrations of needle-free Intraject sumatriptan to the same anatomic site.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
injection
The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema).
Each of the 18 participants were injected three times (for a total of 54 injections)with Sumavel DosePro, and followed over three days.
Time frame: -15 min, immediately Post-dose, and 1, 4, 8, 24, 48 and 72 hrs post-dose
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